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A Clinical Study of GP73 as a Hepatocellular Carcinoma (HCC) Tumor Mark

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ClinicalTrials.gov Identifier: NCT00902902
Recruitment Status : Unknown
Verified May 2009 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : May 15, 2009
Last Update Posted : May 15, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

The aims of this study were divided into three parts:

  1. To evaluate the sensitivity and specificity of GP73 for the diagnosis of hepatitis B related HCC. Established the standard of GP73 in normal people.
  2. To definitude the connections between the GP73 level and various diseases.
  3. To find the relations of HCC metastasis and recurrence.

Study design:

  1. Collectivity type: Prospective,randomized, controlled, multi-central clinical study.
  2. Patients: The subjects were from different hospitals including: Peking Union Medical College Hospital (PUMCH), The Cancer Hospital of Peking Union Medical College (PUMC), QiDong Cancer Institute, and Department of Surgery University of Chicago from November of 2007 till the end of this study.

Study arrangement:

This study was consisted of three parts:

  1. Established the standard of normal people and test the sensitivity and specificity of HCC patients. The samples were acquired from Health Screen Center and Department of liver surgery of PUMCH, The Cancer Hospital of PUMC and QiDong Cancer Institute.
  2. Extend the study bound, including the hepatitis B virus (HBV) and hepatitis C virus (HCV) carriers. The HBV (+) samples were come from Chinese hospitals and institutions. The HCV (+) samples were provide by the Department of Surgery University of Chicago.
  3. Research the relations of serum GP73 level and the other diseases, such as other malignant liver tumors, liver metastatic tumors, liver benign tumor, HCC recurrence following surgery etc.

Condition or disease
Hepatocellular Carcinoma

Study Design

Study Type : Observational
Estimated Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Clinical Study of GP73 as a HCC Early Tumor Mark
Study Start Date : January 2008
Primary Completion Date : December 2008
Estimated Study Completion Date : July 2009
Groups and Cohorts

Group/Cohort
1
2


Outcome Measures

Biospecimen Retention:   Samples With DNA
Human serum

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The subjects were from different hospitals including: Peking Union Medical College Hospital, The Cancer Hospital of PUMC, QiDong Cancer Institute, and Department of Surgery University of Chicago from November of 2007 till the end of this study.
Criteria

Inclusion Criteria:

  • A group of patients with no history of liver disease, alcohol consumption less than 40g a week, and no risk factors for viral hepatitis were enrolled from the General Internal Medicine clinics. All subjects in this control group were documented to have normal liver biochemistry.
  • Consecutive patients with HCC and patients with HBV & HCV that were age, gender, and race/ethnicity matched to the HCC patients were enrolled from the Liver Clinic during this period. The diagnosis of HCC was made by histopathology, and if histopathology was not available by two imaging modalities (ultrasound [US], magnetic resonance imaging [MRI], or computed tomography) showing a vascular enhancing mass >2cm. HBV infection status was based on hepatitis B surface antigen (HBsAg). HCV infection status was based on serum HCV antibody and HCV-RNA positive.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902902


Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: M. Millis, Dr.       mmillis@surgery.bsd.uchicago.edu   
Principal Investigator: M Millis, M.D.         
Sponsors and Collaborators
Peking Union Medical College Hospital
More Information

Responsible Party: Dr. Yilei Mao, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT00902902     History of Changes
Other Study ID Numbers: PUMCH-Liver surgery -GP73
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009

Keywords provided by Peking Union Medical College Hospital:
Hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases